BEUDAMED
    FDA Recall Terminated

    Cepheid Xpert Flu A Panel (GXFLUPANEL-CE-10), manufactured by Cepheid, Sunnyvale, CA. Indicated as an automated multiplex real-time RT-PCR assay for use in labroatories for the in vitro qualitative detection and differentiation of 2009 H1N1 influenza viral RNA.

    Recall: Z-1652-2010 · Initiated February 19, 2010

    Recall

    Recall Number
    Z-1652-2010
    Event Number
    55079
    Firm
    Cepheid
    FEI Number
    3004530258
    Product Code
    OPU
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 19, 2010
    Posted
    May 25, 2010
    Terminated
    March 23, 2011
    Address
    904 E Caribbean Dr, Sunnyvale, CA, 94089-1189

    Description

    Cepheid Xpert Flu A Panel (GXFLUPANEL-CE-10), manufactured by Cepheid, Sunnyvale, CA. Indicated as an automated multiplex real-time RT-PCR assay for use in labroatories for the in vitro qualitative detection and differentiation of 2009 H1N1 influenza viral RNA.

    Reason

    Firm has had an increasing number of customer complaints regarding higher than expected Indeterminate Test Results due to "Invalid" test reports from our system when they have been conducting their own internal validation studies using banked frozen repository specimens.

    Action

    Cepheid issued a notification to consignees regarding the affected product. Additional instructions were provided to consignees in order to avoid further "Indeterminate Results". For further information, contact Cepheid at 1-888-336-2743.

    Distribution

    Worldwide Distribution -- United States, France, Belgium, Germany, Norway Austria, Denmark, Spain, Taiwan and Hong Kong.

    Quantity

    944 kits